Legal Issues in Pain Medicine

1
Controlled Substances and the Law
Katherine E. Galluzzi, D.O., CMD, FACOFP
dist.Professor and ChairpersonDept. of
GeriatricsPhiladelphia College of Osteopathic
Medicine
2
Prevalence of Chronic Pain in U.S.
1 in 4 Americans suffers from chronic pain
Back pain is one of the most common causes of
long-term disability
1. American Pain Foundation. Overview of American
Pain Surveys. Available at http//www.painfoundat
ion.org/page.asp?fileNewsroom/PainSurveys.htm.
Accessed on April 24, 2007. 2. American Pain
Foundation. Pain Facts Figures. Available at
http//www.painfoundation.org/page.asp?fileNewsro
om/PainFacts.htm. Accessed on April 24, 2007.
3
Impact of Unrelieved Pain
American Pain Foundation. Overview of American
Pain Surveys http//www.painfoundation.org/Voices
/VoicesSurveyReport.pdf.
4
New Illicit Drug Use in the United States 2005
SAMHSA. Results from the 2005 National Survey on
Drug Use and Health. DHHS Publication No. SMA
06-4194. 2006.
5
Legal Consequences for Physicians

• Overtreatment of pain
• Undertreatment of pain

• Medical Boards
• Courts
• Legislatures

6
The Cost of Prescription Opioid Abuse in the
United States
Total Cost 2001 8.6 billion Total Cost
2005 9.5 billion
1.4 billion
1.4 billion
4.6 billion
4.6 billion
2.6 billion
2.6 billion
Prescription opioid abuse is a significant public
health problem
Includes costs related to prescription opioid
(RxO) abuse treatment and excess medical costs of
RxO abusers Includes direct costs of the
criminal justice system and victims of crime as a
result of RxO abuse Includes direct and
indirect workplace costs that may be associated
with RxO abuse.
Birnbaum H, et al. Clin J Pain. 200622667-676.
7
Obligations of Physicians

• Adherence to the Central Principle of Balance
• Pain and Policy Studies Group. Achieving Balance
  inFederal and State Pain Policy A Guide to
  Evaluation, 3rd Ed. Madison,WI
  http//www.painpolicy.wisc.edu
• Adherence to the Federation of State Medical
  Board Policy on Controlled Substances
• Model policy for the use of controlled substances
  for the treatment of pain. Federation of State
  Medical Boards of the United States Inc, 2004
  http//www.fsmb.org

8
Central Principle of Balance

• While opioid analgesics are controlled drugs,
  they are also essential drugs and are absolutely
  necessary for the relief of pain. Opioid
  analgesics should be accessible to all patients
  who need them for relief of pain. Governments
  must take steps to ensure the adequate
  availability of opioids for medical and
  scientific purposes . . .

9
Paradigm Shift in Opioid Prescribing

• Competing Public Health Crises
• Under Treated Pain
• Prescription Drug Abuse
• Increasing Need for Safe Effective Pain
  Management
• Decreased barriers to appropriate opioid use
• Increased safety in opioid use

10
Pain and the Medical Board
11
Pain and the Medical Board

• Several egregious actions against MDs
• Details are hard to come by
• Black Box Phenomenon
• Trend may be shifting
• Away from acting against over-prescribing
• Toward acting against under-treating

12
Thursday, September 2, 1999
Case Marks Big Shift in Pain Policy
In an apparent first for the nation, an Oregon
medical board acts against a doctor primarily for
undertreatment of pain It appears to be the
first time in the nation that a state medical
board has taken action against a doctor in which
undertreatment of pain rather than
overtreatment is a primary factor
13
Medical Board Cases Against Physicians for UNDER
Treatment

• TWO Cases with Official Sanctions
• Oregon 1999
• Bildner
• California 2003
• Whitney
• Only after first case of elder abuse went w/o
  action

14
1st Elder Abuse Case

• Bergman family sues Dr. Chin for elder abuse
• Following failed MBC request for help
• No option for malpractice case
• Sponsored by Compassion in Dying Federation
  (CIDF)
• Initial jury verdict
• 1.5 million (subsequently reduced)
• Lead to New Calif. Law (AB 487)
• CME Requirement
• MBC requirement for public disclosure
• NOTE- Chin case (1st Elder Abuse)
• based on a NATIONAL STANDARD

15
2nd Elder Abuse Case

• Tomlinson family sues for elder abuse
• No option for malpractice case
• Sponsored by Compassion in Dying Federation
  (CIDF)
• Settled prior to court hearing
• MD, Hospital, Nursing Home
• MBC sanctions MD involved
• Only 2nd time for US Medical Board
• 1st case without serious pattern

16
Medical Board Cases Against Physicians for OVER
Treatment

• Numerous
• Hard to know all the facts
• Usually closed process
• Decisions may be public but the underlying facts
  usually are not
• Standard of Care?

17
Model Policy for the Use of Controlled Substances
for the Treatment of Pain
Federation of State Medical Boards of the United
States, Inc.

• FSMB House of Delegates
• May 2004
• Available www.fsmb.org

18
FSMB Model PolicyBasic Tenants

• Pain management is important and integral to the
  practice of medicine
• Use of opioids may be necessary for pain relief
• Use of opioids for other than a legitimate
  medical purpose poses a threat to the individual
  and society

19
FSMB Model Policy

• Physicians have a responsibility to minimize the
  potential for abuse and diversion
• Physicians may deviate from the recommended
  treatment steps based on good cause
• Not meant to constrain or dictate medical
  decision-making

20
FSMB Model Policy

• Complete patient evaluation
• Written treatment plan
• Informed patient consent and agreement for
  treatment
• Periodic review of the course of treatment
• Willingness to refer
• Maintenance of complete and current medical record

21
Pain in the Courts
22
Civil Suits For Undertreatment of Pain

• Medical malpractice
• Unskillful practice
• Beneath the standard of care
• Resulting in injury to the patient
• Failure to exercise the required degree of care,
  skill and diligence under the circumstances
• Previously reserved for over-treatment
• Transformation into Elder Abuse

23
Criminal Charges For Overtreatment of Pain

• Numerous High Profile Cases
• Exceptionally few
• Relative to the of MDs treating pain
• Almost all are extreme
• Good clinicians
• Practicing at extremes of the normal curve
• Well intentioned clinicians
• Practicing below standard of care
• Clinicians practicing outside of medicine
• Illegal activities

24
Criminal Activity vs. Medical Incompetence

• Disturbing Trend
• Unclear line between
• Incompetent medical practice
• VS
• Criminal activity
• Egregious/Illegal physician behavior

25
Pain in the Criminal Courts

• Several cases of questionable criminal
  prosecution of Physicians
• Variable outcomes
• California Frank Fisher
• Federal William Hurwitz
• Federal Ronald McIver

26
Final Policy Statement September 6, 2006

• Banner from DEA website on 9-6-06

27
Final Policy Statement September 6, 2006

• Final Policy Statement Sept 2006
• Dispensing Controlled Substances for the
  Treatment of Pain
• Registrant responsibility TO PREVENT diversion
  and abuse
• Citing Gonzales v. Oregon
• Properly determine a legitimate medical purpose
  for the prescription of a controlled substance
• Act in the usual course of professional practice

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Final Policy Statement September 6, 2006

• As a condition of being a DEA registrant
• A physician prescribing controlled substances has
  an obligation to take reasonable measures to
  prevent diversion
• Interim Report described physicians
  responsibility to minimize abuse and diversion
• Why the change from MINIMIZE to PREVENT?

29
Refilling Prescriptions Issuance of Multiple
Prescriptions

• Approved 2007
• Individual practitioner may issue up to a 90-day
  supply of a SII controlled substance authorizing
  the patient to receive a total of up to a 90 day
  supply of a SII substance provided the following
  are met
• Ea. Separate Rx is issued for a legitimate
  medical purpose bu an individual acting in the
  usual course of practice
• Individual practitioner clearly writes Do Not
  Fill Before instructions on the prescription

Fed Register, 2007 GOVT-LAW\C-IIMultipRxs.htm
30
Refilling Prescriptions Issuance of Multiple
Prescriptions

• Written instructions on ea. Rx (other than the
  1st Rx) indicating the earliest date on which a
  pharmacy may fill the Rx
• Individual physician concludes that providing the
  pt w/ mult. Rxs in this manner does not
  constitute an undue risk of diversion or abuse
• Permissable under applicable state laws, etc.

Fed Register, 2007 GOVT-LAW\C-IIMultipRxs.htm
31
Refilling Prescriptions Issuance of Multiple
Prescriptions

• Nothing in this paragraph shall be construed as
  mandating or encouraging individual practitioners
  to issue multiple prescriptions or to see their
  patients only once every 90 days when prescribing
  Schedule II controlled substances. Rather,
  individual practitioners must determine, on their
  own, based on sound medical judgment, and in
  accordance with established medical standards,
  whether it is appropriate to issue multiple
  prescriptions and how often to see their patients
  when doing so.

Fed Register, 2007 GOVT-LAW\C-IIMultipRxs.htm
32
Prescription Drug Abuse

• Physicians must perform risk assessments on
  patients at risk for potential abuse. This is
  particularly true for patients entering opiate
  therapy for chronic pain
• Interpretation
• Physicians have a role in law enforcement
• Greatest role in highest risk patients

White House Press Release National Drug Control
Strategy, 2004
33
Prescription Drug Abuse

• We are now closing this gap in part through the
  development of something most Americans assume
  already existsstate-level prescription
  monitoring programs. PMPs, as they are known, are
  designed to facilitate the collection, analysis,
  and reporting of information on the prescribing,
  dispensing, and use of pharmaceuticals

White House Press Release National Drug Control
Strategy, 2004
34
Prescription Drug Abuse

• The effectiveness of PMPs can be seen in a
  simple statistic in 2000, the five states with
  the lowest number of OxyContin prescriptions per
  capita all had PMPs.
• According to DEA, the five states with the
  highest number of prescriptions per capita all
  lacked them

White House Press Release National Drug Control
Strategy, 2004
35
THE NATIONAL ALL SCHEDULES PRESCRIPTION
ELECTRONIC REPORTING ACT OF 2005(NASPER
H.R.3015)

• National Prescription Monitoring Program
• Promise of improving pain care
• Greater oversight of abusible drugs
• Clinical utility at point of care
• Risks associated w/ chilling effects on pain
  control
• Clear message to prescribers
• Confidentiality concerns
• Variable PMP plans

36
THE NATIONAL ALL SCHEDULES PRESCRIPTION
ELECTRONIC REPORTING ACT OF 2005(NASPER
H.R.3015)

• National Prescription Monitoring Program
• Promise of improving pain care
• Greater oversight of abusible drugs
• Clinical utility at point of care
• Risks associated w/ chilling effects on pain
  control
• Clear message to prescribers
• Confidentiality concerns
• Variable PMP plans

37
Pain in the LawConclusions

• Laws effecting pain management are developing
  across the land
• Almost all are in support of treating
• US Congress with 2 new Federal bills
• National Pain Care Policy Act of 2007
• Military and Veterans Pain Care Act of 2007

38
Electronic Track Trace - RFID

• Secures integrity of drug supply chain by
  providing accurate drug "pedigree,"
• A record documenting that the drug was
  manufactured and distributed under secure
  conditions. We particularly advocated for the
  implementation of and noted that radio-frequency
  identification (RFID) is the most promising
• RFID technology
• Tiny radio frequency chip containing essential
  data in the form of an electronic product code
  (EPC).
• Each discrete product unit has a unique
  electronic serial number
• Product can be tracked electronically through
  every step of the supply chain

RFID radiofrequency identification
39
RFID

• Drug pedigree or tracking systems
• FDA recommends widespread use of RFID in the
  pharmaceutical supply chain by 2007
• FDA considering mandatory RFID pedigree systems
  for Rx shipments

RFID radiofrequency identification
40
Agonist/Antagonist

• Sequestered antagonist
• Bioavailable antagonist
• Antagonists are released only when agent is
  crushed for extraction

41
Alpharma

• Morphine Naltrexone
• Extended-release opioid with a sequestered core
  of the antagonist, naltrexone, in a single dosage
  form
• If product taken as directed
• Intended that the naltrexone will remain
  sequestered and the patient will achieve pain
  relief
• If the capsule is tampered with by crushing,
  chewing or dissolving
• expected that the naltrexone will be released and
  euphoria will be abated

42
Kadian Versus Abuse-deterrent Long-acting Opioid
(ALO-01)
43
Abuse-Deterrent Opioid Formulations in Development
IR immediate-releaseGershell L, Goater JJ.
Nature Reviews Drug Discovery 5. 20065889-890.
44
CONCLUSIONSRemaining Questions

• Requirements for reduced abuse liability label
  claim
• ? Bioequivalence to existing product?
• Short-term evaluation of therapeutic efficacy?
• Long-term studies in susceptible populations?
• ? Acceptable risk?

45
CONCLUSIONSRemaining Questions

• ? DEA scheduling for new abuse-resistant products
  
• ? Lower scheduling
• ? Will all products in class be required to show
  similar reduced abuse liability

46
(No Transcript)
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Opioid Treatment of Chronic Pain
Other Therapies for Pain
Initial Patient Assessment
Trial of Opioid Therapy
Dose Adjustment
Add Long-Acting Opioid
Patient Reassessment
Opioid Rotation
Discontinue Opioids (Exit Strategy)
Katz N. Patient Level Opioid Risk Management.
Available at www.painedu.org/manual.asp.
Accessed February 12, 2007.
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Goals of Chronic Pain Treatment

• Decrease pain to a meaningful degree without
  causing harm
• Increase function
• Physical capacities
• Cognitive capacity
• Improve quality of life
• Mood, sleep, work, social interaction, recreation
• Prevent, treat adverse effects

American Society of Anesthesiologists Task Force
on Pain Management, Chronic Pain Section.
Practice Guidelines for Chronic Pain Management.
Anesthesiology. 199786995-1004.
49
Controlled Substances and the LawConclusions

• Medical boards struggle to find their role
• Courts appear to target exceptional cases
• Lines between bad medicine and criminal activity
  need clarification
• Work in progress

50
Risk Management with Opioids

• Certain
• It is required
• Uncertain
• What it is
• Who needs what parts??
• Does it improve outcomes??